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Model Number DRIVER SHAFT, T-15, MEDIUM |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On (b)(6) 2023, it was reported by a sales representative via (b)(4) that an ar-9545-t15-02 driver is twisted.This was discovered during use in a case with no patient harm.
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Search Alerts/Recalls
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